When the transposition of Directive 90/219/EEC in Belgium was discussed, it was rapidly recognised amongst the negotiators that an implementation at regional level should be favoured, thus confirming the choice already made at the European level to recognize the environmental scope of this Directive. The objective of the transposition of this Directive into national law was not only to ensure its harmonised implementation between the three Regions, but also to improve certain legal and scientific weakness points existing in the European text. The legal basis on which Directive 90/219/EEC was adopted gave the Member States the option of adopting more stringent protection measures, should they so wish.
Firstly, unlike Directive 90/220/EEC, which applies to all genetically modified organisms, Directive 90/219/EEC only applies to genetically modified microorganisms (GMMs), i.e. bacteria, fungi, parasites and viruses. Organisms such as plants and animals were therefore not covered by this Directive. The regional authorities corrected this limitation of the scope by also guaranteeing a risk assessment of genetically modified plants and animals used in laboratories, greenhouses or animal housing. This made it possible for appropriate containment measures to be adopted if necessary to protect human health and the environment during activities involving all types of GMOs.
Secondly, the scope of the Directive, even extended to GMOs, left out non-genetically modified organisms having pathogenic properties for humans, plants or animals. The authorities decided to include these organisms within the scope of the regional regulations, based on the following arguments:
- Laboratories that use GMOs also occasionally handle non-genetically modified pathogenic strains;
- The safety of contained use activities involving GMOs is assessed taking into account the characteristics of the gene donor and acceptor organisms, particularly their pathogenicity for humans, plants or animals;
- The authorities wanted to avoid differences between the containment levels established in Directive 90/219/EEC and those required by Directive 90/679/EEC (relating to the protection of workers from risks related to exposure to biological agents at work), which applies to human pathogens, including those that are genetically modified. The same kind of reasoning applies to phytopathogens and zoopathogens, in order to avoid differences between the "contained use" regulation and other plant- or animal-health legislation establishing containment criteria and levels for the use of quarantine pathogens.
Unlike the extension of the scope of application to GMOs, the extension to all non-genetically modified pathogenic microorganisms is specific to Belgium.
|The inclusion in the regional regulations of phytopathogenic organisms led, in 1995 and 1996, to bitter discussions between the regional and federal authorities and the SBB. Certain authorities were very reluctant to include this type of organisms in the "contained use" legislation in a generic way, either because they believed that their use in small quantities under laboratory conditions posed little or no environmental risk, or (for quarantine phytopathogens) because their use was already subject to the provisions of the Federal decrees relating to the control of organisms harmful to plants and plant products. These criticisms were taken into account in the preparation of the reference lists of phytopathogenic microorganisms and the containment criteria to be applied during their use.|
Thirdly, the Directive provides for the classification of GMMs into two groups: group I (no risk to human health or the environment) and group II (all other organisms presenting a risk). This classification was not consistent with the internationally accepted system set up by the World Health Organization (WHO) for classifying biological risks into four risk categories, ranging from risk group 1 (no risk to human and animal health) to risk group 4 (the most pathogenic microorganisms). The regional authorities chose to adopt the WHO classification for the transposition of Directive 90/219/EEC.
Consequently, with a view to ensuring preventive management of risks to the environment and human health, the Regions adopted a very broad biosafety regulatory framework coherent on the scientific level, that covers all living organisms that pose a risk to human health and the environment.
A scientific consequence of this decision was the drawing up by the Biosafety and Biotechnology Unit (SBB) of reference lists of microorganisms which, in their natural form, pose a risk to immunocompetent humans and animals or healthy plants. Several hundred microorganisms were thus listed and assigned to a class of risk based on existing international classifications, lists of microorganisms or pathogenic organisms recognised by other countries, and an in-depth analysis of the scientific literature. These lists were appended to the regional legislation and form an internationally recognised reference source. These lists have been updated several times by the SBB to take account of new scientific data concerning nomenclature, taxonomy and classes of risk.
|The transposition of Directive 90/219/EEC and certain amendments published in the interim by the European Commission led to the publication of three separate decrees:
The three transposition decrees were each integrated into the general framework of regional environmental legislation applicable to Classified Installations.
The harmonised transposition of Directive 90/219/EEC in Belgium was therefore completed before the adoption of the Cooperation Agreement. However, it was largely inspired by the general objectives and principles of that agreement.
The revision of the regional decrees
In 1998, Directive 90/219/EEC was amended by Directive 98/81/EC. The transposition of this new Directive was performed from 2000 under the responsibility of an ad hoc biosafety group established by the CCIEP (Coordination Committee for International Environmental Policy, an interface between the Belgian federal and regional authorities and international environmental organisations. Its main task is to organise consultations between the federal and regional authorities to ensure that the national implementation of recommendations and decisions taken at an international level is well coordinated).
This ad hoc group consisted of representatives from the Regions and their legal professionals. The Biosafety and Biotechnology Unit (SBB) was mandated to act as the group's secretariat and to provide expertise on the technical and regulatory GMO aspects. The ad hoc group's main responsibility was to define the harmonisation points to transpose Directive 98/81/EC.
The ad hoc group's activities relating to the transposition of the Directive started on the basis of a draft decree of the Flemish Region. This draft has been developed in 1997 by the LNE administration ("Leefmilieu-, Natuur en Energie", which was previously called AMINAL, "Administratie Milieu-, Natuur-, Land- en Waterbeheer"), as part of a working group "Subcommittee on Hazardous Substances" in consultation with academics, industry and the SBB.
The various parties aimed to do more than simply review the regional decrees on the contained use of GMOs and pathogens based on the provisions of the new Directive. Other aspects were also taken into consideration, such as:
- The adjustment of the regulations to make them correspond better to what is happening in the field and to current experience, while keeping protection of public health and the environment at the highest level as possible;
- Suggestions from academics and industry, the competent authorities and the public;
- The necessity to integrate the jurisprudence;
- The publication by CEN (European Committee for Standardisation) of biotechnology norms which were considered a very useful technical complement to the implementation of the regulations;
- The necessity to emphasise inspection even more, including the role of the regional inspection services (according article 17 of the Directive), because the initial regional regulations mainly focused on permit policy and regularisation of installations;
- The increasing need (including the legal obligations) for public information and participation;
- The precautionary principle, particularly in the context of the European Commission's communication on the subject (Commission communication on the precautionary principle. COM (2000) February 2, 2000).
For the transposition of Directive 98/81/EC, it was decided to keep the extended scope including GMOs and pathogens. The environment legislation applying to installations categorised as high-risk continued also to be the general framework for this implementation. Specific regulations from each Region were also taken into account.
With regard to the draft decrees for the three Regions, the ad hoc group agreed on about twenty harmonisation points that were all included in the working group's conclusions. These were related to procedures, but also decisions on issues such as:
- The allocation of responsibilities and the management of biosafety in the installations (who are considered "users" as defined in the Directive, the appointment of a Biosafety Officer (or Coordinator) and in some cases of a Biosafety Committee);
- The management of waste resulting from activities of class of risk 1, for which Directive 98/81/EC does not impose inactivation (it was decided to make the inactivation of such waste compulsory according to a validated method);
- The control by biological sampling with regard to the traceability of GMOs and pathogens.
The ten months in which the ad hoc group on biosafety worked together offered the opportunity to achieve the harmonisation referred to in the cooperation agreement on biosafety. This provided the three Regions with a foundation they could used to work further on the transposition texts.
Directive 98/81/EC was transposed for the Brussels Capital Region on November 8, 2001, for the Flemish Region on February 6, 2004 and for Wallonia on July 4, 2002. These legislation are still in force.
Directives 90/219/EEC and 98/81/EC have since been replaced by Directive 2009/41/EC, which consolidated Directive 90/219/EEC and subsequent amendments 94/51/EC, 98/81/EC and Council Decision 2001/204/EC.